A Phase 3 interventional study of Deucravacitinib and Placebo in Systemic Lupus Erythematosus, sponsored by Bristol-Myers Squibb. Active, not recruiting at 180 sites in 22 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 513 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: Deucravacitinib
Other: Placebo
Specified dose on specified days
Specified dose on specified days
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Time frame: At week 52
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Time frame: At week 52
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Time frame: At week 52
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
Time frame: At week 52
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Time frame: At week 52
Proportion of participants with oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52
Time frame: At week 52
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Time frame: At week 52
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time frame: At week 52
Number of participants with adverse events (AEs)
Time frame: Up to 156 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 156 weeks
Number of participants with AEs leading to discontinuation of treatment
Time frame: Up to 156 weeks
Number of participants with AEs leading to study discontinuation
Time frame: Up to 156 weeks
Number of participants with target adverse events of special interest (AESIs)
Time frame: Up to 156 weeks
Number of participants with laboratory abnormalities
Time frame: Up to 156 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 156 weeks
Number of participants with vital sign abnormalities
Time frame: Up to 156 weeks
Showing the first 100 of 180 sites across 22 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Bristol-Myers Squibb